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Surveillance for Early Liver Injuries Caused by Xianlin Gubao Granule

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ClinicalTrials.gov Identifier: NCT03091608
Recruitment Status : Unknown
Verified March 2017 by Xiaohe Xiao, Beijing 302 Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Xiaohe Xiao, Beijing 302 Hospital

Brief Summary:
This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Granule (XLGB Granule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Granule.

Condition or disease
Drug-Induced Liver Injury

Detailed Description:

The primary objectives of this study include:

(i) The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to XLGB Granule.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Weeks
Official Title: A Registry Study to Surveil Early Liver Injuries Caused by Xianlin Gubao Granule (XLGB Granule)
Estimated Study Start Date : March 25, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Group/Cohort
The individuals taking XLGB Granule
The overall individuals taking XLGB Granule with recommended dosage and achieving the inclusion criteria.



Primary Outcome Measures :
  1. The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule. [ Time Frame: participants will be followed duration intake of XLGB Granule, an expected average within 8 weeks ]
    The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule.


Secondary Outcome Measures :
  1. Clinical features of early liver injuries caused by XLGB Granule assessed by serum parameters of liver function. [ Time Frame: participants will be followed duration intake of XLGB Granule, an expected average of 8 weeks ]
    Clinical features of early liver injuries caused by XLGB Granule assessed by serum parameters of liver function.


Other Outcome Measures:
  1. Disease progression of early liver injuries caused by XLGB Granule, i.e. death, liver failure, chronic DILI, recovery. [ Time Frame: 8 weeks ]
    Disease progression of early liver injuries caused by XLGB Granule, i.e. death, liver failure, chronic DILI, recovery.


Biospecimen Retention:   Samples With DNA
serum, plasma, histology and urine.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
community sample and primary care clinic.
Criteria

Inclusion Criteria:

  1. Individuals in accordance with indications for XLGB Granule, including osteoporosis, fracture, osteoarthritis, aseptic necrosis of bone and climacteric;
  2. The age range of 18 to 70 years;
  3. Individuals taking XLGB Granule over 2 weeks;
  4. Abnormalities of serum liver biochemistry achieving one of the criteria as follows:

    (i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) ≥2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) ≥ 2 ULN; (iii) alkaline phosphatase (ALP) ≥ 2 ULN;

  5. Individuals can provide informed consent form.

Exclusion Criteria:

  1. Individuals without indications for XLGB Granule;
  2. Unconformity to the XLGB Granule drug label;
  3. Individual taking XLGB Granule less than 2 weeks;
  4. Individuals taking other hepatotoxic drugs combined with XLGB Granule, simultaneously;
  5. Unconformity to the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091608


Contacts
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Contact: Xiao-he Xiao +86 66933322 pharmacy302xxh@126.com
Contact: Jia-bo Wang +86 66933323 pharm_sci@126.com

Locations
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China, Beijing
302 Military Hospital
Beijing Shi, Beijing, China, 100039
Sponsors and Collaborators
Beijing 302 Hospital
Investigators
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Study Director: Xiao-he Xiao 302 Military Hospital

Additional Information:

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Responsible Party: Xiaohe Xiao, Director, Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT03091608     History of Changes
Other Study ID Numbers: 302-xxh-XLGBG
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaohe Xiao, Beijing 302 Hospital:
Drug-Induced Liver Injury
Additional relevant MeSH terms:
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Chemical and Drug Induced Liver Injury
Wounds and Injuries
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning